What side effects are associated with this type of intervention?

Common treatments for advanced or metastatic prostate cancer, such as chemotherapy (e.g., docetaxel, cabazitaxel), androgen deprivation therapy (ADT), and newer agents like abiraterone, have distinct side effect profiles. Chemotherapy can cause myelosuppression, neutropenia, fatigue, nausea, and neuropathy. ADT often leads to hot flashes, decreased libido, osteoporosis, and metabolic changes. Abiraterone is associated with hypertension, hypokalemia, and liver function abnormalities. Newer therapeutic agents like RO7656594, while still under study, may have side effects similar to other targeted therapies, including fatigue, gastrointestinal disturbances, and potential hematologic toxicities.

What prior FDA approvals exist?

Several FDA-approved treatments for advanced or metastatic prostate cancer include androgen receptor signaling inhibitors like enzalutamide and abiraterone, which block the effects of androgens that can promote tumor growth. Radiopharmaceuticals such as radium-223 (Ra-223) target bone metastases by delivering radiation directly to bone tumors. Immunotherapies like sipuleucel-T, a dendritic cell vaccine, have also been approved for castration-resistant prostate cancer. Additionally, PARP inhibitors like rucaparib and niraparib are approved for patients with specific genetic mutations. These treatments aim to manage disease progression and improve survival outcomes in patients with advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to RO7656594 for prostate cancer treatment include: 1) NLG207 in combination with enzalutamide, which has shown effectiveness in preclinical models of enzalutamide-resistant prostate cancer. 2) Olaparib, particularly for patients with homologous recombination repair gene alterations, as it has demonstrated improved radiographic progression-free survival and overall survival in clinical studies. 3) Lutetium-177-PSMA-617, which has shown potential to extend overall survival with a favorable toxicity profile in metastatic castration-resistant prostate cancer. 4) BAT (Bipolar Androgen Therapy), which has shown promise in restoring sensitivity to abiraterone and enzalutamide in patients with metastatic castration-resistant prostate cancer.

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Monoclonal Antibodies

RO7656594 for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up multiple timepoints from cycle 1 day 1 up to approximately 12 months (1 cycle= 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called RO7656594 to see if it is safe and effective for people with advanced prostate cancer. The study focuses on patients whose cancer has spread and may not respond to current treatments. Researchers are looking at how the drug moves through the body and its impact on cancer cells to find the best dose and schedule for future studies.

Who is the study for?

This trial is for men with advanced or metastatic prostate cancer who have already tried at least one second-generation hormone therapy and a taxane chemotherapy, unless they can't tolerate or refused the chemo. They should be relatively active and able to care for themselves (ECOG ≤1).

What is being tested?

The study is testing RO7656594's safety, how it affects the body, and its effectiveness in treating prostate cancer. Participants will receive different doses of RO7656594 to find out what amount works best for future studies.

What are the potential side effects?

Possible side effects of RO7656594 are not specified here but generally may include typical reactions like nausea, fatigue, allergic responses, or other drug-specific effects which will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ multiple timepoints from cycle 1 day 1 up to approximately 12 months (1 cycle= 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~multiple timepoints from cycle 1 day 1 up to approximately 12 months (1 cycle= 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and multiple timepoints from cycle 1 day 1 up to approximately 12 months (1 cycle= 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Plasma Concentration of RO7656594

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stage 2: ExpansionExperimental Treatment1 Intervention

Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Group II: Stage 1: Dose EscalationExperimental Treatment1 Intervention

Participants will receive RO7656594 administered at a specified dose on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy agents like docetaxel work by disrupting cell division, leading to cancer cell death. Immunotherapy, such as sipuleucel-T, stimulates the patient's immune system to attack cancer cells. Targeted therapies, including those being studied like RO7656594, aim to interfere with specific molecular pathways critical for cancer cell survival and proliferation. Understanding these mechanisms is crucial for prostate cancer patients as it helps in selecting the most appropriate treatment based on the cancer's specific characteristics and genetic profile, potentially improving outcomes and minimizing side effects.

Update in the management of patients with hormone-refractory prostate cancer.Overview of international collaborative group prostate cancer trials.